Pancreatic cancer is one of the leading causes of cancer death in the United States and has the worst prognoses of major cancers as illustrated by almost the same incidence (32,800) and mortality (31,800) rates and an overall 5-year survival rate <5%. The reason for this grim prognosis is that most pancreatic cancers are diagnosed at a stage when the option of a curative surgical resection is not available. Presently, no current imaging studies including high-resolution CT, MRI, endoscopic ultrasound (EUS), and endoscopic cholangiopancreatography (ERCP) can reliably detect pancreatic tumors at potentially resectable stage. Current imaging modalities as well as ERCP utilize the presence of a mass lesion, and, therefore, even if the resolution of these tests is improved, the tumor detected is likely biologically too advanced for cure.
Despite years of research, no clinically effective molecular markers have been developed. Importantly, widespread pancreatic cancer screening by means of examination of the pancreatic duct (e.g., ERCP) is not feasible given that interrogation of the pancreatic duct including biopsy, fiber-optic evaluation, and/or brushing may lead to serious complications in ˜20% cases, including acute pancreatitis (˜5%), which is a potentially life-threatening condition. Thus, this approach may not be suitable for routine screening over successive points in time but may be appropriate for selective situations in which the suspicion for an advanced precursor lesion or early staged tumor is high.